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ANIP FDA Decision Approved · 2025-03-14

Updated ·next FDA decision on the calendar

Price into the decision (T-120)

PDUFA 3/14/25$63.26$53.359/27/24
Daily close, T-120 (9/27/24) through T+5. Run-up high $63.26 on 3/12/25, low $53.35 on 12/27/24 (T-120 to T-1). FDA decision 3/14/25. Historical price action, not a forecast.
Positioning before the decision
On Feb 28, 2025, 14 days before the decision date, at-the-money options priced a move of ±8.0% through Mar 21, 2025 (the first listed expiry after the decision; ATM implied volatility 55%). The stock closed +1.7% at the first close across the decision and +4.7% five trading days on. A straddle priced weeks out covers ordinary movement plus the event, so this is the move the options market priced through that expiry, not the event-implied move alone. How this compares across 1,000+ decisions.

Decision facts

FDA decision date2025-03-14
DrugILUVIEN (fluocinolone acetonide intravitreal implant)
IndicationChronic non-infectious uveitis affecting the posterior segment of the eye (NIU-PS) in addi
Outcome✓ Approvedprimary-sourced
Decision-day move+1.7%
T-120 run-up (low→high)+4.0% ($53.35→$64.35)
Market-cap tierMid
Cohort decision-day move (history)2.1% median (n=234)

Cohort move is the historical median absolute decision-day move for this market-cap tier across our run-up study. History, not a prediction.

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Questions

Was ILUVIEN (fluocinolone acetonide intravitreal implant) approved by the FDA?

Yes. The FDA approved the application for ILUVIEN (fluocinolone acetonide intravitreal implant) on March 14, 2025. The primary source is linked on this page.

What was ILUVIEN (fluocinolone acetonide intravitreal implant) under FDA review for?

The application covered Chronic non-infectious uveitis affecting the posterior segment of the eye (NIU-PS) in addi. The FDA approved the application on March 14, 2025.

How did ANIP stock react to the FDA decision?

On the decision day ANIP moved +1.7%. That is the recorded reaction to this specific event -- historical measurement, not a prediction, and not investment advice.